“On this Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. We stay committed and focused on innovation and product development; this is yet another achievement for the multidisciplinary teams at Bharat Biotech,” stated Suchitra Ok. Ella, Joint Managing Director, Bharat Biotech.
“If approved, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy to administer formulation and delivery device. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern,” she stated.
COVID-19 Intranasal Vaccine
Two separate and simultaneous scientific trials have been performed to guage BBV154 as a main dose (two-dose) schedule; and a heterologous booster dose for topics who’ve beforehand acquired two doses of the 2 generally administered COVID vaccines in India.
Information from each Section III human scientific trials have been submitted for approval to nationwide regulatory authorities, the corporate stated.
BBV154 (intranasal vaccine) is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated earlier in part I and II scientific trials with profitable outcomes.
Main dose schedule part III trials have been performed for security, and immunogenicity in about 3,100 topics, and in contrast with Covaxin. The trials have been performed in 14 trial websites throughout India.
Heterologous booster dose research have been performed for security and immunogenicity in about 875 topics, the place a booster dose (third dose) of BBV154 intranasal vaccine was administered to review individuals who have been beforehand vaccinated with licensed COVID vaccines. The trials have been performed in 9 trial websites throughout India.
Being an intranasal vaccine, BBV154 might produce native antibodies within the higher respiratory tract which can present the potential to cut back an infection and transmission. Additional research are being deliberate, the vaccine-maker stated.
BBV154 has been particularly formulated to permit intranasal supply. As well as, the nasal supply system has been designed and developed to be cost-effective in low and middle-income international locations.
The intranasal was developed in partnership with Washington College St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical research for efficacy.
Product improvement associated to preclinical security analysis, large-scale manufacturing scale-up, formulation, and supply system improvement, together with human scientific trials, have been performed by Bharat Biotech. The Authorities of India partly funded product improvement and scientific trials by means of the Division of Biotechnology’s, COVID Suraksha program.